Yang, C.K., Wu, C.E., & Liaw, C.C. (2016). Combination of palonosetron, aprepitant, and dexamethasone as primary antiemetic prophylaxis for cisplatin-based chemotherapy. Biomedical Journal, 39, 60–66. 

DOI Link

Study Purpose

To evaluate the efficacy of the triple drug combination of palonosetron, aprepitant, and dexamethasone for chemotherapy-induced nausea and vomiting (CINV) prevention

Intervention Characteristics/Basic Study Process

The antiemetic regimen was 0.25 palonosetron IV prior to chemotherapy, 125 mg aprepitant on day 1 and 80 mg on days 2–3, and 20 mg dexamethasone IV on day 1 and 5 mg dexamethasone IV every 12 hours after chemotherapy. Antiemetic rescue of either diphenhydramine or metoclopramide was used as needed. Nausea and vomiting were recorded daily during hospital stay and by patients daily after discharge. Evaluation was done across two cycles.

Sample Characteristics

  • N = 69   
  • MEDIAN AGE = 61 years
  • AGE RANGE = 32–81 years
  • MALES: 61%, FEMALES: 30%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: All were scheduled to receive at least 50mg/m2 cisplatin. Patients had varied tumor types, of which esophageal and genitourinary were most prevalent.
  • OTHER KEY SAMPLE CHARACTERISTICS: All were chemotherapy naive.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Taiwan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Observational

Measurement Instruments/Methods

  • Complete response (CR) defined as no emesis and no rescue
  • Nausea reported on four-point scale from none to severe (bedridden because of nausea)

Results

The CR rate was 100% in the acute phase and 96.7% in the delayed phase. During the first cycle, the CR rate of no nausea was 98.6% during the acute phase and 87% in the delayed phase. The CR rate reported was exactly the same in the acute phase for the second cycle, and rates for no nausea were similar to those in cycle 1.

Conclusions

The triple drug antiemetic regimen used here was shown to be effective. The CR rates reported here are higher than seen in other studies, and during the acute phase, dexamethasone was given IV rather than PO, as done in most outpatient studies.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement validity/reliability questionable
  • Nausea rating and timing not well described

Nursing Implications

This study aligns with a significant volume of evidence showing the effectiveness of a standard triple drug regimen for CINV prophylaxis in patients receiving highly emetogenic chemotherapy.